In situ forming hemostatic foam implants
Inventors
Sharma, Upma • Gitlin, Irina • Zugates, Gregory T. • Rago, Adam • Zamiri, Parisa • Busold, Rany • Freyman, Toby • Caulkins, Robert J. • Pham, Quynh P • You, Changcheng • Carbeck, Jeffrey D.
Assignees
Publication Number
US-10765781-B2
Publication Date
2020-09-08
Expiration Date
2030-08-24
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Abstract
Systems and methods related to polymer foams are generally described. Some embodiments relate to compositions and methods for the preparation of polymer foams, and methods for using the polymer foams. The polymer foams can be applied to a body cavity and placed in contact with, for example, tissue, injured tissue, internal organs, etc. In some embodiments, the polymer foams can be formed within a body cavity (i.e., in situ foam formation). In addition, the foamed polymers may be capable of exerting a pressure on an internal surface of a body cavity and preventing or limiting movement of a bodily fluid (e.g., blood, etc.).
Core Innovation
The invention provides systems and methods relating to polymer foams that are formed in situ within a body cavity to control the movement of bodily fluids such as blood. Specifically, a flowable, synthetic hydrophobic polymer material is introduced into a body cavity and foamed within the cavity by reacting with water naturally present in the environment, which produces CO2 gas. This gas expands the polymer material more than 12-fold, forcing it into interstitial spaces and forming an elastomeric foam that comes into conformal contact with tissue surfaces, including actively bleeding injuries.
The core problem addressed is the difficulty in controlling bleeding and stabilizing wounds, especially internal injuries that are not amenable to traditional compression or are located in tortuous or inaccessible regions of the body. Existing polymer materials and methods suffer from limitations such as tissue irritation, poor biodegradability, inadequate mechanical properties, or challenges with delivery and placement inside body cavities.
By utilizing a formulation that cross-links and foams upon contact with bodily moisture, the invention enables rapid and targeted expansion of the foam, creating a temporary implant that physically limits or prevents the movement of bodily fluids. The polymer compositions may be adjusted for mechanical properties, hydrophilicity or hydrophobicity, and can incorporate additional functionalities such as drug delivery or contrast agents for visualization. The material can be designed to be biodegradable and biocompatible, and is intended to remain effective for at least several hours, facilitating temporary control of bleeding until surgical intervention is available.
Claims Coverage
The patent contains one independent claim that outlines the main inventive features related to in situ formation of synthetic hydrophobic polymer foams in body cavities for fluid control.
In situ formation of polymer foam within a body cavity to control movement of bodily fluid
A method comprising: - Placement of a synthetic hydrophobic material into a body cavity of a living subject. - Foaming the hydrophobic polymer material while within the body cavity to form a foam. - Limiting movement of a bodily fluid with the foam, relative to movement that would occur in the absence of the foam. - The foaming step involves reaction of the hydrophobic polymer material with water present in the body cavity, generating CO2 gas, which expands the polymer material more than 12-fold and forces it into interstitial areas of the cavity.
The inventive features collectively focus on the method of forming an expanding hydrophobic polymer foam in situ within a body cavity, using water-induced CO2 generation to provide fluid control.
Stated Advantages
Foams reach injury sites located within tortuous body cavities, around anatomical features, through pooled blood, and/or against blood flow.
Formulations enable easy delivery of polymer throughout a body cavity, with viscosity and wetting properties tailored for injection and rapid expansion.
Polymer foams are conformal, filling cavities and coating tissue surfaces even when injury sites are unknown.
Foams can be biocompatible, biodegradable, and possess tunable mechanical properties to support internal tissues without interfering with physiological functions.
Foams exhibit high expansion, low viscosity, and adjustable pore architecture for optimized capillary action and fluid absorption.
Hydrophobic formulations facilitate movement and conformal contact in vivo, minimizing interference with bodily functions.
Polymer foams can facilitate hemostasis by reducing blood flow, supporting clot formation, and creating seals at sites of injury.
Provides a temporary implant that limits fluid movement for a desirable period (e.g., at least 3 hours), buying time for surgical intervention.
Polymer foams can be engineered for controlled removal and degradation, including triggered breakdown by external stimuli.
Documented Applications
Treatment of incompressible hemorrhage from wound sites in body cavities, particularly where wound sites are unknown or unvisualized.
Stabilization and control of bleeding from organs (e.g., liver, spleen) or tissues damaged by trauma, including blunt trauma.
Filling body cavities created by tissue loss to limit or prevent the movement of bodily fluids such as blood, bile, digestive fluids, or interstitial fluid.
Formation of implants to limit or prevent movement of bodily fluids in the cavity for hours to days as a temporary hemostatic measure.
Limiting or preventing tissue adhesions following injury or surgical intervention by placing polymer foam between tissues.
As a carrier for drug delivery, including drugs such as antifibrinolytics, antimicrobials, anti-inflammatories, analgesics, pro-coagulants, growth factors, and vasoconstrictors.
Use of foams to aid in visualization of body cavities when combined with contrast agents.
Treatment of burns and external wounds by forming or applying the polymer foam outside of a body cavity.
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